(1) Adulterated – any shellfish harvested from closed waters; any shellfish shucked, packed, or otherwise processed in a facility which has not been certified by the Department in accordance with the requirements of these rules; any shellfish contaminated as determined by microbiological or other analysis; any shellfish consisting in whole or in part of any filthy, putrid or decomposed substance, or otherwise unfit for food; any shellfish prepared, packed, or held under unsanitary conditions where it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
    (2) Alternative Processing – any processing done to shellfish which does not follow the time-temperature matrix as stated in subparagraphs 5L-1.008(7)(a)1.-3. and Fl. Admin. Code R. 5L-1.008(7)(b)
    (3) Approved harvest area – an area in which it is indicated by a sanitary survey or other monitoring program data that fecal material, pathogenic microorganisms, radio nuclides, harmful chemicals, and marine biotoxins are not present in dangerous concentrations.
    (4) Aquaculture Use Zones – legally-defined parcels that are surveyed, describing and indicating corners and boundaries, that have been subdivided into individual aquaculture leases issued pursuant to Florida Statutes § 253.68, and Fl. Admin. Code R. 18-21.004(2)(m)
    (5) Authorized User – an Aquaculture Certificate of Registration holder authorized by an aquaculture leaseholder to operate on the sovereign submerged state land aquaculture leases and listed on a valid Aquaculture Leaseholder and Authorized User Acknowledgment form.
    (6) Certification period – the period of time between July 1 and June 30 of a year.
    (7) Certified shellfish facility – the location, structures and equipment that has been certified pursuant to rule Chapter 5L-1.005, F.A.C., as a shellstock shipper, shucker-packer, or repacker. The certified shellfish facility shall comply with all laws, rules, and permits applicable to the shellfish business operation.
    (8) Closed area (closed waters) – an area where the harvesting of shellfish is not permitted. Closed areas include prohibited and unclassified areas as well as temporarily closed approved, conditionally approved, restricted, and conditionally restricted harvest areas.
    (9) Code – the Comprehensive Shellfish Control Code, rule Fl. Admin. Code Chapter 5L-1
    (10) Commercial harvester – a person that harvests with the intent to sell.
    (11) Conditionally approved harvest area – an area in which it is indicated by a sanitary survey or other monitoring program data that the area is subjected to intermittent microbiological pollution and, under such conditions, is temporarily unsuitable as a source of shellfish for direct marketing. Such an area shall be managed by an operating procedure that will assure that shellfish from the area are not harvested from waters not meeting approved area criteria.
    (12) Conditionally restricted harvest area – an area in which it is indicated by a sanitary survey or other monitoring program data that the area is subjected to intermittent microbiological pollution and, under such conditions, is temporarily unsuitable as a source of shellfish for relaying or depuration. Such an area shall be managed by an operating procedure that will assure that shellfish from the area are not harvested from waters not meeting restricted area criteria.
    (13) Corrective action plan – is a brief outline of the deficiency(ies) found during an inspection of a certified facility with the corresponding rule deficiencies cited and the time frame in which the deficiency(ies) must be corrected.
    (14) Critical control point – a point, step, or procedure in a food process at which control can be applied, and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.
    (15) Critical deficiency – a condition or practice which may result in the production of a product that is adulterated. A critical deficiency presents a threat to the health or safety of the consumer.
    (16) Critical limit – the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.
    (17) Deficiency – a condition or practice that is not in compliance with the rules governing the operation of the facility as outlined in rule Fl. Admin. Code Chapter 5L-1, “”The Comprehensive Shellfish Control Code.””
    (18) Department – the Department of Agriculture and Consumer Services.
    (19) Depuration facility (controlled purification plant) (DP) – a shellfish processor who obtains shellstock from approved, conditionally approved, restricted or conditionally restricted harvest area(s) and submits such shellstock to a Department approved controlled purification process. The treatment process is designed to purge shellfish of bacterial and viral contamination to the extent that such shellfish are rendered safe for human consumption.
    (20) Designated representative – is the individual who supervises all activities associated with the operation of the certified shellfish facilty in the absence of the facility owner or facility supervisor.
    (21) Emergency – any unusual incident resulting from natural or unnatural causes which endangers the health, safety, or resources of the state, including, but not limited to, a hurricane, storm, or red tide; petroleum spill; toxic substance discharge; inability of a sewage treatment plant to comply with permit conditions due to a breakdown of equipment, power outage, destruction by fire, wind, or by other cause.
    (22) Facility supervisor – an individual who supervises all activities associated with the operation of the certified shellfish processing facility.
    (23) Food – any raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption. Shellfish in the shell are considered food.
    (24) Food contact surface – a surface of equipment or utensil which food normally comes into contact; or a surface of equipment or utensil from which food may drain, drip, or splash into food or onto a surface normally in contact with food.
    (25) Food packaging materials – any material or container which food normally comes into contact.
    (26) Food safety hazard – any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.
    (27) Free liquor – that liquid portion of a container that passes through a porous straining device when the contents (oyster or clam meats) of the container are drained.
    (28) HACCP – Hazard Analysis and Critical Control Points – A system of inspection, control, and monitoring measures initiated by a shellfish processor to identify and control microbiological, chemical, or physical food safety hazards which are likely to occur in shellfish products produced by the facility.
    (29) Harvest – removal and subsequent possession of shellstock. Temporary possession of shellfish for the purpose of culling shall not constitute harvesting if after culling undersized shellstock are immediately returned to the water in the same shellfish harvesting area.
    (30) Harvester – a person engaged in the harvesting of shellfish.
    (31) Health authority – the Department or its authorized representative.
    (32) Heat shock – the process of subjecting molluscan shellstock to any form of heat treatment prior to shucking, including steam, hot water or dry heat, to facilitate removal of the meat from the shell without substantially altering the physical or organoleptic characteristics of the molluscan shellfish.
    (33) ICWW – Intracoastal Waterway.
    (34) Key deficiency – a condition or practice which may result in adulterated, misbrandedor, or unwholesome product.
    (35) Lot of shellstock – a single type of bulk shellstock or container of shellstock of no more than one day’s harvest from a single harvest area gathered by one or more harvesters.
    (36) Lot of shucked shellfish – a collection of containers of no more than one day’s shucked product from a single harvest area produced under conditions as nearly uniform as possible, and designated by a common container code or marking.
    (37) Lot wet storage/depuration – all shellfish from a single depuration or wet storage tank or series of tanks serviced by a common treatment system.
    (38) Mechanical refrigeration – refrigeration provided by a compressor in a system where temperature can be adjusted with a thermostat and the unit will maintain a temperature of 45°F or less.
    (39) Misbranded – any shellfish product whose labeling is false or misleading; any shellfish product in package form unless it bears labeling including (1) the name and place of business of the manufacturer, packer, or distributor; (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; and (3) meets labeling requirements of the Department within this chapter.
    (40) NSSP Model Ordinance – the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, published by the U.S. Department of Health and Human Services.
    (41) Other deficiency – a condition or practice that is not in accordance with rule requirements and is not determined to be a key or critical deficiency.
    (42) Pest – refers to any objectionable animals or insects, including, but not limited to, dogs, cats, birds, rodents, flies, and larvae.
    (43) Processing – is the handling, unloading, storing, transporting, shucking, freezing, preparing, changing into different market form, manufacturing, preserving, packing, or labeling of shellfish or shellfish products.
    (44) Prohibited harvest area – an area from which the taking of shellfish is not permitted.
    (45) Public Water System – a system for the provision to the public of water for human consumption through pipes or other constructed conveyances, if such system has at least fifteen service connections or regularly serves an average of at least twenty-five individuals daily at least 60 days out of the year. Such term includes: any collection, treatment, storage, and distribution facilities under control of the operator of such system and used primarily in connection with such system; and any collection or pretreatment storage facilities not under such control which are used primarily in connection with such system. Such term does not include any “”special irrigation district.”” A public water system is either a “”community water system”” or a “”non-community water system.”” See the Code of Federal Regulations (C.F.R.), Title 40, Part 141, Section 2, revised as of July 1, 2015, incorporated in Fl. Admin. Code R. 5L-1.001(6)(b)
    (46) Remote Buying – a shellfish processor or designated representative taking possession of shellfish at any location different than their certified shellfish processing facility location.
    (47) Repacker/Repacking Facility (RP) – a certified shellfish facility, other than the original certified shucker-packer, who repacks shucked shellfish into other containers for distribution or sale. A repacker may also purchase, repack and ship shellstock. A repacker shall not shuck shellfish.
    (48) Repeat Critical deficiency – is the same “”critical”” deficiency that has been listed on the corrective action plans for the same facility anytime during the preceeding 180 days.
    (49) Repeat Key deficiency – is the same “”key”” deficiency that has been listed on the corrective action plans for the same facility anytime during the preceeding 180 days.
    (50) Repeat Other deficiency – is the same “”other”” deficiency that has been listed on the corrective action plans for the same facility anytime during the preceeding 180 days.
    (51) Restricted harvest area – an area in which it is indicated by a sanitary survey or other monitoring program data that fecal material, pathogenic microorganisms, radio nuclides, harmful chemicals, and marine biotoxins are not present in dangerous concentrations such that shellfish harvested from such an area and subjected to a suitable and effective purification process are safe for human consumption.
    (52) Restricted Use Shellstock – shellstock that is harvested from harvest areas classified as approved or conditionally approved in the open status and under conditions that do not allow the sale of shellstock for direct marketing for raw consumption. Restricted use shellstock is identified with a green tag indicating the shellstock is intended for shucking by a certified processing facility or post harvest processing only.
    (53) Retail sale – sale to the ultimate consumer or to a person who will not resell the product.
    (54) Sanitize – the effective bactericidal treatment of clean food contact surfaces of equipment and utensils by a process using only those safe sanitizing agents that have an available field test for strength and effectiveness, and is effective to yield a reduction of 5 logs, which is equal to a 99.999% reduction of representative disease microorganisms of public health importance. Such treatment shall not adversely affect the product and shall be safe for the consumer.
    (55) Shellfish – all edible species of oysters, clams, mussels, and whole or roe-on scallops either shucked or in the shell, fresh, or frozen.
    (56) Shellfish Processor – a shellstock shipper, shucker-packer, or repacker who possesses a shellfish processing facility certification from the Department.
    (57) Shellfish Relaying – the transfer of shellfish from an aquaculture lease closed for the harvest of shellfish to a certified depuration facility or another aquaculture lease open for the harvest of shellfish, pursuant to Fl. Admin. Code R. 5L-1.009
    (58) Shellstock – shellfish which remain in their shells.
    (59) Shellstock shipper/Shellstock shipping facility (SS) – a certified shellfish facility which buys, repacks and sells shellstock. A shellstock shipper is not authorized to shuck shellfish nor to repack shucked shellfish but may also buy and sell sealed containers of shucked shellfish.
    (60) Shuck date – the date shucked shellfish are initially removed from their shells.
    (61) Shucked shellfish – shellfish or parts thereof which have been removed from their shells.
    (62) Shucker-packer/Shucker-packer facility (SP) – a certified shellfish facilty which shucks and packs shellfish. SPs may act as a shellstock shipper and/or repacker.
    (63) Swing deficiency – a deficiency that could either be a “”critical”” or a “”key”” deficiency, or it could be either a “”key”” or an “”other”” deficiency, depending on the location, severity and circumstances.
    (64) Time of Harvest – is defined as the time when shellfish are first removed from the water and placed on or in a manmade conveyance or other means of transport.
    (65) Time of Refrigeration – is defined as the time when shellfish are first placed within an ambient environment of 45°F degrees or less.
    (66) Unclassified area – an area for which no recent sanitary survey exists. Harvest of shellfish is not permitted.
    (67) Unwholesome – shellfish which are not in sound condition, unclean, or otherwise not suitable for human consumption.
    (68) UV – Ultraviolet.
    (69) Violation and deficiency – are used interchangeably within these rules. The meaning of both is that a facility is not in compliance with the rules governing their operation as outlined in rule Fl. Admin. Code Chapter 5L-1, “”The Comprehensive Shellfish Control Code.””
    (70) Warning letter – a warning letter includes a notice of non-compliance.
    (71) Wet storage – the temporary storage of shellfish harvested from an approved sources or in the open status conditionally approved harvest area and placed in tanks containing water that meets approved or open status conditionally approved shellfish harvesting area water quality standards.
    (72) Wholesale – any sale to any person or business other than the final consumer.
Rulemaking Authority 597.020 FS. Law Implemented Florida Statutes § 597.020. History-New 1-4-87, Amended 5-21-87, 8-10-88, 7-9-89, 11-5-92, 5-20-93, Formerly 16R-7.003, Amended 7-3-95, 5-8-96, 2-6-97, 6-23-99, Formerly 62R-7.003, Amended 8-9-00, 5-29-02, 3-23-17, 4-2-19, 1-18-23.